Devices

Biofourmis AI Physiological Monitor Cleared

FDA has cleared a Biofourmis 510(k) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. The device “receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages AI and machine learning to identify the correlation between multiple vital signs and the patient’s daily activities, building an individualized biometric signature that is dynamically updated based on incoming data,” the company says. The physiologic readings are computed into a “Biovitals Index,” which alerts providers to changes in patients’ vital signs from their baseline, the company says.

The clearance was based on data from clinical studies involving monitored patients with complex chronic conditions such as heart failure, COPD and atrial fibrillation, who were at home in a real-world setting. For example, in one study, the company says, the device “enabled earlier clinical intervention by predicting heart failure decompensation 12 days in advance of a heart failure-related hospitalization in a 73-year-old man — who had multiple comorbidities, including hypertension, COPD and diabetes — by combining multivariate physiology signals to generate actionable insight for clinicians to intervene.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome